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Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle SL291

by Sterilucent, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850012210085 UDI-DI Date29 Apr 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle
Generic Name
Biological sterilization indicator
Model / Ref / Catalog
SL291
Primary DI / UDI-DI
00850012210085
FDA Product Code
FRC
GMDN Term
Biological sterilization indicator
Device Class
Class II
Regulation Number
880.2800
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No